Iodine alcoholic solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Potassium iodide; Purified water; Ethanol 90%

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

D08AG03

INN (International Name):

Potassium iodide; Purified water; Ethanol 90%

Dosage:

25mg/1ml ; ;

Pharmaceutical form:

Cutaneous solution

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13110400

Patient Information leaflet

IODINE TINCTURE
(iodine, potassium iodide)
IMPORTANT INFORMATION ABOUT IODINE TINCTURE
• This medicine is an antiseptic for use on minor wounds.
• It can be used on adults and children.
DO NOT USE….
• On newborn infants.
• On large open wounds.
• Highly flammable. Keep away from naked flames, lit cigarettes and
some devices (e.g.
hairdryers).
NOW READ THE REST OF THE LEAFLET BEFORE YOU USE THIS MEDICINE. IT
INCLUDES OTHER
INFORMATION WHICH MIGHT BE ESPECIALLY IMPORTANT FOR YOU.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need any more information or advice.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
1. WHAT THE MEDICINE IS FOR
Iodine Tincture contains iodine which is an antiseptic. It is for use
on minor wounds, cuts and
scrapes.
2. BEFORE YOU USE THIS MEDICINE
DO NOT USE THE MEDICINE IF YOU OR YOUR CHILD HAVE….
• An ALLERGY to any of the ingredients listed in section 6.
• A thyroid problem.
• Lithium therapy for manic depression.
• Or on newborn infants.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU OR YOUR CHILD ARE HAVING….
• Tests on the thyroid as Iodine Tincture may interfere with the
results.
PREGNANT OR BREASTFEEDING….
Ask your doctor or pharmacist for advice before using this medicine if
you are pregnant,
might be pregnant or are breastfeeding. Iodine Tincture should not be
used in pregnancy or
breastfeeding unless the doctor has told you to do so.
THIS MEDICINE CONTAINS 85.4% V/V ALCOHOL (ETHANOL) IN EACH APPLICATION
It may cause burning sensation on damaged skin.
3. HOW TO USE THIS MEDICINE
Apply it to the skin.
• Do not use for long periods.
• Do not use on large open wounds.
• Do not cover with a dressing after use.
ADULTS, THE ELDERLY AND CHILDREN
i
• Apply to the affected area using cotton wool as required.
FOR EXTERNAL USE ONLY.
IF YOU SWALLOW SOME
If you accidentally swallow some see a doctor straight away.
Take the pack wit

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Alcoholic Iodine Solution BP
Iodine Tincture BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodine 2.5% w/v, Potassium Iodide 2.5% w/v
Excipients of known effect
Ethanol 85.4% v/v
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cutaneous solution.
Adark brown, clear, mobile liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As an antiseptic for use on minor wounds, cuts and abrasions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use.
The product is suitable for use by adults, children and the elderly.
Apply to the affected part with cotton wool or a small brush.
4.3
CONTRAINDICATIONS
Contraindicated for patients hypersensitive to iodine or iodides.
Contradicted for use in newborn infants.
Contradicted in patients with thyroid disorders or those receiving
lithium
therapy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid prolonged use.
For external use only.
Keep all medicines out of the sight and reach of children.
Solutions of iodine applied to the skin should not be covered with
occlusive
dressings, (otc packs to state the shortened warning, “DO NOT
COVER”).
Do not use on large, open wounds.
Highly flammable. Instruct patients to keep away from naked flames,
lit cigarettes
and some devices (e.g. hairdryers).
Ingredients with known effects
This medicine contains 85.4% v/v alcohol (ethanol) in each
application. It may cause
burning sensation on damaged skin.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Administration of this product may interfere with tests of thyroid
function.
4.6
PREGNANCY AND LACTATION
Use with caution during pregnancy and lactation. Iodides cross the
placenta
and are excreted in breast milk.
4.7
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None or negligible influence.
4.8
UNDESIRABLE EFFECTS
May cause allergic reactions, including urticaria, angioedema,
cutaneous
haemorrhage or purpuras, fever, arthralgia, lymphadenopathy and
eosinophilia.
REPORTIN